2026-03-052026 年 3 月Mar 2026
NDC 码 12 位新规终规发布：2033 年 3 月 7 日生效FDA Finalizes 12-Digit NDC Format, Effective March 7, 2033
FDA 在 2026 年 3 月 5 日发布终规，将国家药品代码（NDC）统一为 12 位 6-4-2 格式。这是 NDC 几十年来最大的一次格式调整，药品（含 OTC）出口企业须提前规划系统与标签升级。On March 5, 2026, FDA published the final rule unifying National Drug Codes (NDC) into a 12-digit 6-4-2 format — the biggest format change in decades. Drug (including OTC) exporters must plan system and label upgrades ahead.
- 时间线：2026–2033 共 7 年准备期，2033–2036 共 3 年过渡期。Timeline: a 7-year preparation period (2026–2033) plus a 3-year transition (2033–2036).
- 条码：一维或二维二选一；符合条件时单个 2D DataMatrix 可同时满足 FDA 标签与 DSCSA 产品标识要求。Barcoding: linear or 2D — either is acceptable; a single 2D DataMatrix can satisfy both FDA labeling and DSCSA product identifier requirements where applicable.
- 现在要做的 4 件事：ERP/MDM/EDI 支持 12 位、规划标签切换、评估扫描设备、DSCSA 主数据同步。Four things to do now: make ERP/MDM/EDI 12-digit-ready, plan label changeover, assess scanning hardware, align DSCSA master data.
资料来源：FDA 终规原文；正式申报以 FDA 原文为准。Source: FDA final rule; official filings should follow the FDA original text.
2026-10-012026 年 10 月Oct 2026
2026 年食品设施注册续期窗口：10 月 1 日–12 月 31 日2026 Food Facility Registration Renewal: Oct 1 – Dec 31
2026 年是食品设施注册的续期年。所有在美国生产、加工、包装、仓储食品的境内外企业，须在 10 月 1 日至 12 月 31 日完成两年一次的续期。2026 is a food facility registration renewal year. All domestic and foreign facilities manufacturing, processing, packing, or holding food for the US must complete biennial renewal between October 1 and December 31.
- 未按时续期会被从 FDA 注册库除名，影响后续对美出口清关。Missing renewal means removal from FDA's registry, affecting future customs clearance for US-bound shipments.
- FDA 食品设施注册不收官费（$0），但信息须准确、联系人邮箱须有效。FDA charges no fee for food facility registration ($0), but information must be accurate and contact emails valid.
- 境外企业续期同样需要美国代理人配合确认。Foreign facilities likewise need their US Agent's coordination for renewal.
资料来源：FDA 食品设施注册要求（21 CFR Part 1 Subpart H）；正式申报以 FDA 原文为准。Source: FDA food facility registration requirements (21 CFR Part 1 Subpart H); official filings should follow the FDA original text.
2026-10-012026 年 10 月（FY2027）Oct 2026 (FY2027)
FDA 2027 财年官费更新：申报前先确认当年标准FDA FY2027 User Fees: Confirm the Current-Year Schedule Before Filing
FDA 2027 财年（2026 年 10 月 1 日起）使用者费用已经更新。涉及申报的企业，注意按新标准预算：FDA's FY2027 user fees (effective October 1, 2026) are updated. Companies planning submissions should budget to the new schedule:
- 510(k)：标准 $28,653，小企业 $7,163。510(k): standard $28,653, small business $7,163.
- 医疗器械企业年费：$13,785。Medical device establishment annual fee: $13,785.
- OMUFA（OTC 专论）：MDF 设施 $47,891，CMO $31,927。OMUFA (OTC monograph): MDF facility $47,891, CMO $31,927.
- 食品设施注册官费：$0（FDA 不收费）。Food facility registration: $0 (no FDA fee).
以上为 FDA 官方费用，每年调整；资料来源为 FDA 各使用者费用项目官方页面。我们的服务费另计，签约前书面确认。These are official FDA fees, adjusted yearly; see FDA's user fee program pages. Our service fees are separate and confirmed in writing before engagement.
2024-07-01持续进行Ongoing
MoCRA 进入执法常态：化妆品合规不能再拖MoCRA Enforcement Is the New Normal: Cosmetics Compliance Can't Wait
自 2024 年 7 月 1 日 FDA 开始正式执法以来，MoCRA 的设施注册与产品列名已成为化妆品进入美国市场的标配。FDA 的执法重点包括未注册设施、未列名产品，以及标签与成分问题。Since FDA began active enforcement on July 1, 2024, MoCRA facility registration and product listing have become table stakes for cosmetics entering the US market. Enforcement focuses on unregistered facilities, unlisted products, and labeling/ingredient issues.
- 境外企业必须指定美国代理人，这是注册的前置条件。Foreign companies must designate a US Agent — a prerequisite for registration.
- 注册之后还有持续义务：信息更新、严重不良事件 15 个工作日内报告。Ongoing duties continue after registration: keeping information current and reporting serious adverse events within 15 business days.
- 防晒、祛痘、止汗等功效宣称的产品可能按药品（OTC）监管，先做品类判定。Products claiming sunscreen, acne, or antiperspirant effects may be regulated as (OTC) drugs — determine the category first.
资料来源：MoCRA 法案与 FDA 化妆品项目页面；正式申报以 FDA 原文为准。Source: the MoCRA statute and FDA's cosmetics program pages; official filings should follow the FDA original text.
